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Antibiotic

Lefamulin for Mycoplasma Genitalium Infection

Phase 1 & 2
Waitlist Available
Led By Lisa E Manhart, PhD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Physician referral
Persistent symptomatic urogenital M. genitalium infection documented by any nucleic acid amplification test (NAAT) 14-90 days after completion of the prior antimicrobial regimen for M. genitalium
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days from initial study start if randomized to lefamulin alone; 49 days from initial study start if randomized to lefamulin and doxycycline
Awards & highlights

Study Summary

This trial will test whether the antibiotic Xenleta can cure Mycoplasma genitalium infections when other antibiotics have failed, and whether taking doxycycline first makes it more effective.

Eligible Conditions
  • Mycoplasma Genitalium Infection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days from initial study start if randomized to lefamulin alone; 49 days from initial study start if randomized to lefamulin and doxycycline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days from initial study start if randomized to lefamulin alone; 49 days from initial study start if randomized to lefamulin and doxycycline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Microbiologic cure
Secondary outcome measures
Clinical cure
Microbiologic cure after lefamulin alone compared to microbiologic cure after doxycycline followed by lefamulin
Reported adherence to lefamulin
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lefamulin aloneExperimental Treatment1 Intervention
Lefamulin 600mg tablet orally twice daily for 7 days
Group II: Doxycycline followed by lefamulinExperimental Treatment2 Interventions
Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lefamulin
2015
Completed Phase 1
~40
Doxycycline
2008
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,726 Previous Clinical Trials
1,821,305 Total Patients Enrolled
Nabriva Therapeutics AGIndustry Sponsor
9 Previous Clinical Trials
2,069 Total Patients Enrolled
Lisa E Manhart, PhD, MPHPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical maladies does Lefamulin commonly address?

"Patients with severe acne, disease, or even trachoma may find relief through the administration of Lefamulin."

Answered by AI

Are individuals being onboarded into this trial at the present?

"Affirmative. According to the records found on clinicaltrials.gov, this trial has been open for recruitment since April 22nd 2022 and is still actively searching for 40 participants from one medical site."

Answered by AI

What is the cap on total participants in this research experiment?

"Affirmative. Clinicaltrials.gov has data which implies that this research programme, initially posted on April 22nd 2022, is actively acquiring patients. 40 individuals must be enrolled from a single medical centre."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I've tried other regiments that have not been effective due to resistance and been deterred from others for a lack of tolerance.
PatientReceived no prior treatments
~4 spots leftby Mar 2025